Bloomberg Law
Sept. 10, 2019, 6:02 PM

FDA Warns Drug Maker Over Sterility Violations

Christopher Brown
Christopher Brown
Staff Correspondent

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Sharp Drugs Inc., dba Island Drug and Surgical

  • Issuing Office: Food and Drug Administration, Division of Pharmaceutical Quality Operations
  • Recipient: Joseph Pierro (owner)
  • Date: Aug. 2 (posted Sept. 10)
  • Inspection of facility in West Hampton Beach, N.Y., July 10-13, 2018

Alleged Infractions

  • Drug products intended to be sterile were prepared, packed, or held under insanitary conditions.
  • Company failed to perform adequate smoke studies to demonstrate unidirectional airflow within sensitive areas.
  • Company failed to perform media fills as required.
  • Company informed ...

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